BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADVANCED OPTICS ASPHERIC LENS

    MDR report key: 2309194 · Received October 21, 2011

    Report

    Report Number
    1119279-2011-00207
    Event Type
    Injury
    Date Received
    October 21, 2011
    Report Date
    September 23, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO OF THIS REPORT HAS BEEN OBTAINED FROM THE PHYSICIAN WHILE FOLLOWING UP ON A PREVIOUSLY SUBMITTED MDR#: 1119279-2011-00192. IN ADDITION TO THE PREVIOUSLY REPORTED EVENT (MDR #: 1119279-2011-00192), THE PHYSICIAN REPORTED THAT THERE WERE 5 ADDITIONAL PTS, FOR A TOTAL OF 6 PTS INVOLVING 9 IOLS. THE FOLLOWING IOL SERIAL NUMBERS HAVE BEEN PROVIDED: (B)(4). HOWEVER, NO PT SPECIFIC INFO HAS BEEN PROVIDED. THEREFORE, IT IS UNK AT THIS TIME WHICH SERIAL NUMBER(S) IS/ARE ASSOCIATED WITH EACH PT. THE ADDITIONAL 5 PTS MENTIONED ABOVE CORRESPOND TO THE FOLLOWING MDR#S: 1119279-2011-203, 1119279-2011-204, 1119279-2011-205, 1119279-2011-206, AND 1119279-2011-207. ADDITIONAL INFO HAS BEEN REQUESTED. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT THE AKREOS ADAPT INTRAOCULAR LENS GOT OPACIFIED. THE PT WAS LESS THAN 2 YEARS OLD. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADVANCED OPTICS ASPHERIC LENS INTRAOCULAR LENS HQL BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other